A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07672223
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYS6010 — DRUG
    SYS6010
  • Enlonstobart — DRUG
    Enlonstobart
  • Tislelizumab — DRUG
    administered via Intravenous (IV) injection
  • Toripalimab ±+platinum-based doublet chemotherapy — DRUG
    Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
  • Durvalumab — DRUG
    Durvalumab
  • Pembrolizumab — DRUG
    Pembrolizumab
  • Nivolumab — DRUG
    Nivolumab

Study Details

The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).

Key Dates

First listed
Jun 26, 2026
Start date
Jun 25, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Nov 30, 2031

Study Design

Enrollment
570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6010 + Enlonstobart
  • Active Comparator: Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

Primary Outcome Measure

Disease-Free Survival (DFS) assessed by the independent review committee (IRC) [ Time Frame: Up to approximately 60 months ]

Central Contacts

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